Committee publication · Correspondence · 1 July 2026
Correspondence from Medicines & Healthcare products Regulatory Agency (MHRA), re: Geroprotector research and patient benefit of scientific innovation, 23 March 2026
Summary
The MHRA responds to the Science, Innovation and Technology Committee's February 2026 inquiry into regulatory support for scientific innovation. The agency outlines an ambitious reform programme launched over the past year, emphasising accelerated pathways for medicines and devices while maintaining safety standards. Key initiatives include a new MHRA-NICE aligned approval pathway (launching April 2026), reduced clinical trial timelines (91 to 41 days), and enhanced support for SMEs and early-stage innovators through fee waivers and innovation sandboxes.
Key findings
- New MHRA-NICE aligned approval pathway launches 1 April 2026, reducing time between marketing authorisation and NICE guidance by 3–6 months through integrated assessment and joint scientific advice.
- Clinical trial approval timelines reduced from approximately 91 days to 41 days; pilot programme for 14-day assessments of low-risk trials commencing 28 April 2026.
- Centres of Excellence for Regulatory Science & Innovation (CERSIs) established to strengthen UK expertise in genomics, diagnostics, AI, advanced therapies, and in silico modelling.
- MHRA launched fee waiver pilot scheme in January 2026 for micro and small UK medtech companies; expanded support for SMEs through early scientific advice, webinars, and workshop engagement.
- Rare disease therapy pathway overhaul underway, targeting £340 million in annual delayed-diagnosis costs and £4.7 billion in health-related disability costs; focused collaboration with Newcastle University and ARIA on neurotechnology regulation.
Tone
SupportiveTopics
Key actors
MHRA (Medicines and Healthcare products Regulatory Agency), NICE (National Institute for Health and Care Research Excellence), Dame Chi Onwurah MP, Lawrence Tallon (MHRA Chief Executive), ARIA (Advanced Research and Invention Agency), UK Research and Innovation (UKRI), Newcastle University, FDA (US Food and Drug Administration)
Notable line
“… everything we do is driven by our responsibility to protect and improve public health, ensuring that patients can have confidence in the safety, quality and effectiveness of the medicines and medical devices they rely on.”
Key Quotes
“… everything we do is driven by our responsibility to protect and improve public health, ensuring that patients can have confidence in the safety, quality and effectiveness of the medicines and medical devices they rely on.”
“Our focus has been on creating predictable, proportionate, and innovative pathways, while maintaining rigorous patient safety standards.”
“Clinical trial approval timelines have been reduced from approximately 91 days to 41 days, with a pilot programme for 14-day assessments of low-risk trials ahead of new clinical trials regulations commencing 28 April”
“The pathway for rare disease therapies will be overhauled, aiming to reduce costs associated with delayed diagnosis and limited treatment options, estimated at £340 million annually …”
“Ultimately, this work reflects our unwavering focus on patients, ensuring that scientific innovation translates into real-world benefits more quickly, safely and equitably, while maintaining the public's trust in the UK's regulatory system.”
Source · parliament.uk record ↗